Traumatic Brain Injury Clinical Trials

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Evaluation of Antisecretory Factor in Treatment of Severe Traumatic Brain Injury With Multimodal Monitoring

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study evaluates the addition of Salovum, an egg yolk powder enriched for antisecretory factor, to standard care of participants with severe traumatic brain injury. Half of the participants will be administered Salovum while the other half will be given a placebo egg yolk powder, not enriched for antisecretory factor. Intracranial pressure (ICP), partial brain oxygen pressure (PtbO2), microdialysis of metabolites and inflammatory mediators and trauma intensity level (TIL) will be assessed in all patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 70
Healthy Volunteers: f
View:

• Severe traumatic brain injury, Glasgow Outcome Scale (GCS) \<9 at admission to NICU.

• Clinical indication for insertion of intracranial pressure monitor, intracerebral oxygen pressure monitor and microdialysis catheter.

• Consultation with relatives or consent from guardians.

Locations
Other Locations
Sweden
Skane University Hopsital
RECRUITING
Lund
Contact Information
Primary
Peter Siesjö, MD, PhD
peter.siesjo@med.lu.se
+4646171274
Backup
David Cederberg, MD
david.cederberg@med.lu.se
+4646177655
Time Frame
Start Date: 2020-03-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 20
Treatments
Placebo_comparator: Placebo
Egg yolk powder not enriched for antisecretory powder
Experimental: Salovum
Egg yolk powder enriched for antisecretory powder
Related Therapeutic Areas
Sponsors
Collaborators: Lantmannen Medical AB, Skane University Hospital
Leads: Peter Siesjö

This content was sourced from clinicaltrials.gov